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The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

21 juli 2026 bijgewerkt door: Ruijin Hospital

The goal of this observational study is to learn about neuroimage and biomarkers in the cerebral small vessel disease. The main questions it aims to answer are:

How does neurovascular coupling change during the progression of CSVD?
How is the pattern/mapping of alterations in CSVD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Cerebrale kleine vaatziekte

Gedetailleerde beschrijving

This observational study recruits participants with cerebral small vessel disease (CSVD) from hospitals and community-based populations. Healthy volunteers will also be recruited as controls. Longitudinal follow-up of these participants will help clarify the significance of neuroimaging and biological biomarkers during the development and progression of CSVD.

The investigators aim to establish a longitudinal cohort covering the spectrum of CSVD and identify key biomarkers associated with disease progression and cognitive decline. All participants will undergo multimodal MRI, PET imaging (optional) with different tracers, and blood biomarker assessments. Using multimodal MRI, the investigators will investigate alterations in neurovascular coupling and their role in the pathophysiology of CSVD. In addition, PET imaging (optional) and blood biomarkers will be used to characterize the spatial and temporal patterns of disease-related biomarker changes. Furthermore, additional neuroimaging and digital biomarkers will be evaluated within the cohort to improve disease characterization and prognostic prediction.

Studietype

Observationeel

Inschrijving (Geschat)

400

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200025
    - Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    - Contact:
      
      Jingyan Tian, Dr
      
      Telefoonnummer: 13671865057
      
      E-mail: tjy11488@rjh.com.cn
    - Hoofdonderzoeker:
      
      Jingwen Jiang, Dr.
    - Onderonderzoeker:
      
      Binyin Li, Dr.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.

Beschrijving

Inclusion Criteria:

Age ≥18 years.
Evidence of cerebral small vessel disease (CSVD) on brain MRI, meeting at least one of the following imaging criteria:
- White matter hyperintensities (WMH) with a total Fazekas score ≥2;
- Fazekas score =1 with at least two vascular risk factors (hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoking, or a history of vascular events other than stroke);
- Fazekas score =1 accompanied by the presence of lacunes;
- Imaging evidence of a recent subcortical lacunar infarction.
Independent in activities of daily living (modified Rankin Scale [mRS] ≤2).
Able and willing to provide written informed consent.

Exclusion Criteria:

Acute ischemic stroke with a diffusion-weighted imaging (DWI) lesion >20 mm in diameter.
Acute intracerebral hemorrhage.
Acute subarachnoid hemorrhage, a history of aneurysmal subarachnoid hemorrhage or cerebrovascular malformation, or the presence of an untreated intracranial aneurysm >3 mm in diameter.
Previously diagnosed neurodegenerative disorders, such as Alzheimer's disease (AD) or Parkinson's disease (PD).
Definite non-vascular white matter diseases, including multiple sclerosis, adult-onset leukodystrophy, metabolic encephalopathy, or other non-vascular white matter disorders.
Major psychiatric disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Contraindications to MRI (e.g., severe claustrophobia or MRI-incompatible implants).
Severe systemic diseases (e.g., active malignancy) with an expected life expectancy of less than 5 years.
Inability to complete scheduled follow-up because of geographic, logistical, or other reasons.
Concurrent participation in another interventional clinical trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Cognitively Normal Participants do not have cognitive impairment.
Cerebral small vessel disease without dementia Participants have vascular cognitive impairment, but no cognitive impairment
Vascular Dementia (VaD) Participants have vascular cognitive impairment or difficulty in daily activity.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Global cognitive ability Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Mini-mental state examination	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive function Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Clock drawing test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Visual memory Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Rey-Osterich complex figure test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Short-term memory Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Auditory verbal learning test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive memory Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Symbol-digit test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Spatial executive function Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Trail making test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Naming ability Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Boston naming test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Language ability Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Language fluency test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Sleep quality Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Sleep disorder	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Movement ability Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Part III of the Unified Parkinson's Disease Rating Scale	baseline, 1 year, 2-year, 3-year, 5-year,10-year

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Brain volume Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Annual changes of volumes of brain	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Connectivity integrity of the neural circuit Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Annual changes of hippocampus related neural connectivity	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Volume of white matter lesions Tijdsspanne: baseline, 1 year, 2-year, 3-year, 5-year,10-year	Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR).	baseline, 1 year, 2-year, 3-year, 5-year,10-year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ruijin Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

8 juli 2026

Primaire voltooiing (Geschat)

30 september 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

10 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2026

Eerst geplaatst (Werkelijk)

24 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)